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Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials

FDA Law Blog

Study visits can be conducted using telehealth visits if in-person interaction is not necessary. The draft guidance also states that informed consent can be collected remotely or electronically as part of a DCT, so long as there is institutional review board oversight. Trial personnel can also be sent to participant’s homes.

Clinic 59
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PC Trials at State of Science: Tom LeBlanc, Kate Courtright, & Corita Grudzen

GeriPal

Kate: So it was an embedded alert in the electronic health record and they just clicked those two answers very quickly. I’m just stunned even writing that! We’ve come so far as a field. This is Eric Widera. Alex: This is Alex Smith. Eric: Alex, who do we have with us today? Were you at the GeriPal pub crawl? laughter] Eric: 2:30 AM.

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Anti-Asian Hate: Russell Jeung, Lingsheng Li, & Jessica Eng

GeriPal

I had fun trying to make a danceable version with electronic drums for the audio-only podcast. And to balance the somber subject, Lingsheng requested the BTS song Dynamite, which was the group’s first English language song, and was released at the height of the COVID pandemic. Maybe we’ll get some BTS followers to subscribe to GeriPal?!?

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Telemedicine in a Post-Pandemic World: Joe Rotella, Brooke Calton, Carly Zapata

GeriPal

This DEA is taking 6-months to consider how to move forward vis a vis restrictions and requirements for telehealth in a post-pandemic world. So we’re going to be talking about telemedicine, telehealth for people with serious illness. Now is the time to act, dear listeners! This is Eric Widera. Joe: I do. The Labyrinth version or?